Cebu: 3rd floor, ALP Tower, 609 Tres de Abril St, Cebu City, Cebu

Manila:Unit A, # 286 El Grande Avenue, Phase 3, BF Homes, Parañaque City

Davao: Gov. Generoso St.,Osmeña, Davao City

CTK Biotech

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Adenovirus Ag Rapid Test CE

Features:

No cross-reactivity with 30+ common bacteria and viruses.
CE mark approved for sale in Europe
Ergonomic, user-friendly extraction tube that minimizes contamination
Initial patient care action can begin during the patient’s visit as positive results are visible in as soon as 3 minutes

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0189C	Adenovirus Ag Rapid Test CE	20/kit	Swab

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Chagas Ab Combo Rapid Test CE

Features:

First lateral flow rapid test on the market for Chagas, suitable for use at the point of care
No equipment required
Simple procedure
Detects antibodies including IgG to T. cruzi
Utilizes recombinant antigens to achieve high sensitivity and specificity
Relative Sensitivity: 92.9%, Relative Specificity: 100% in comparison to a commercial EIA
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Plastic droppers
Sample diluent (REF SB-R0171, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0171C	Chagas Ab Combo Rapid Test CE	30/kit	S, P &WB

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Chikungunya IgM Combo Rapid Test CE

Features:

Uses serum, plasma or whole blood specimen
Utilizes recombinant antigen derived from the CHIK structure protein
IgM immunoassay is the most practical lab method
Distinguish from dengue infection which presents with similar symptoms

Clinical performance:

Sensitivity: 90.4%
Specificity: 98.0% comparing to a commercial ELISA
Cross-Reactivity: no cross-reactivity found on 10-40 specimens from the 14 disease states and special conditions, such as dengue, Zika, malaria, HIV, TB, HAV, pregnant woman and others
No interference with some common substances, such as Acetominophen (20 mg/dL), Heparin (3000 U/L), Ascorbic acid (20 mg/dL), Human IgG (1000 mg/dL), Bilirubin (20 mg/dL), Glucose (55 mmol/L), Creatinine (442 μmol/L), Salicylic acid (4.34 mmol/L), EDTA (3.4 μmol/L), Sodium citrate (3.8%)
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (5 μL)
Sample diluent (REF SB-R0066, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0066C	Chikungunya IgM Combo Rapid Test CE	30/kit	S, P &WB

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CMV IgG/IgM Rapid Test

Features:

A lateral flow immunoassay for the simultaneous detection and differentiation of IgM and IgG antibodies to cytomegalovirus (CMV) in human serum, plasma or whole blood.
- Individually sealed foil pouches containing:
a. One cassette device b. One desiccant
- 10 µL capillary tubes
- Sample diluent (REF SB-R0224, 5 mL/bottle)
- One package insert (instructions for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0224C	CMV IgG/IgM Rapid Test	30/kit	S,P& WB

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COVID-19 + Influenza A/B Ag Rapid Test CE

Features:

Aids in identifying SARS-CoV-2, Influenza A, and Influenza B infection, within the first seven days of symptom onset.
Differentiates 3 infections in 1 test.
Efficiently tests for 3 infections with only 1 patient sample.
Easy to use, minimal training required, no lab equipment needed.
All-in-one package for point-of-care use and resource-limited settings.
Results in 15 minutes.
Reagents and Materials Provided:
1. Individually sealed foil pouches containing:
  1. Two cassettes assembled into one panel
  2. One desiccant
2. Sample extraction tubes
3. Sample extraction tube rack
4. Sample extraction buffer (REF SB-R0188, 5 mL/bottle)
5. Nozzles with filter
6. Individually sealed pouches containing a sterile swab
7. Instructions for Use
Materials Required but Not Provided:
- Clock or timer
Materials May be Required but Not Provided:
- Positive control
- Negative Control
- Nasal Swabs

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0188C	COVID-19 + Influenza A/B Ag Rapid Test CE	15/kit	Swab

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COVID-19 Ab Rapid Test

Features:

The OnSite COVID-19 Ab Rapid Test is designed to detect anti-SARS-CoV-2 total antibodies in either serum, plasma or whole blood within 15 minutes. It is presumed that the OnSite COVID-19 Ab Rapid Test may detect SARS-CoV-2 in other species of mammals including mink.
This test is easy to use and does not require the use of laboratory equipment.
REAGENTS AND MATERIALS PROVIDED
1. Individually sealed foil pouches containing:
  1. One cassette device
  2. One desiccant
2. Disposable capillary tubes, marked for 10 µL and 20 µL
3. Detection buffer (tris-based buffered solution with preservatives)
4. Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock, watch or other timing device
2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
4. Collection devices for venous whole blood, serum, plasma
5. Disposable gloves, biohazard disposal container

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0185C	COVID-19 Ab Rapid Test	30/kit	S, P &WB

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COVID-19 Ag Rapid Test CE

Features:

The OnSite COVID-19 Ag Rapid Test has 92.3% sensitivity and 100% specificity, aiding in early diagnosis by detecting viral components.
The OnSite COVID-19 Ag Rapid Test is a qualitative antigen detection test that provides results in 15 minutes.
This test is easy to use and does not require the use of laboratory equipment.
Compatible with CTK Rapid Test Reader (RTR-1)
- 200 tests per hour in batch mode
- Capable of connecting to Laboratory Information System (LIS)
- Built-in barcode reader provides faster test setup
- Stores up to 1,000 results, presented on-screen, via printout, or uploaded to a database
- Reagents and Materials Provided:
  1. Individually sealed foil pouches containing:
    1. One cassette device
    2. One desiccant
  2. Sample extraction tubes
  3. Sample extraction tube rack
  4. Sample extraction buffer
  5. Nozzles
  6. Sterile swabs, each sealed in a plastic-paper pouch
  7. Instructions for Use
  Materials Required but Not Provided:
  - Clock or timer
  Materials May be Required but Not Provided:
  - Positive control
  - Negative control
  - Nasal swab

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0182C	COVID-19 Ag Rapid Test CE	20/kit	Swab

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COVID-19 IgG/IgM Rapid Test CE

Features:

The OnSite COVID-19 IgG/IgM Rapid Test is designed to detect anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.
This test is easy-to-use, with basic equipment needs.
The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% sensitivity and 97.8% specificity, making it one of the most effective tests for detecting previous exposure to anti-SARS-CoV-2 virus.
Finger prick specimen allows testing at point-of-care, saving crucial time.
Complementary to PCR by detecting immune response
Compatible with CTK Rapid Test Reader (RTR-1)
- 200 tests per hour in batch mode
- Capable of connecting to Laboratory Information System (LIS)
- Built-in barcode reader provides faster test setup
- Stores up to 1,000 results, presented on screen, via printout, or uploaded to database
- Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    1. One cassette device
    2. One desiccant
  2. Disposable capillary tubes, marked for 10 µL and 20 µL
  3. Detection buffer (tris-based buffered solution with preservatives)
  4. Instructions for Use
  Materials Required but not provided:
  1. Clock, watch or other timing device
  2. Pipettor capable of delivering 10-20 μL of sample, that can be used instead of the disposable capillary tube for greater accuracy
  3. Sterile lancets, sterile gauze and wipes for fingerstick whole blood specimens
  4. Collection devices for venous whole blood, serum, plasma
  5. Disposable gloves, biohazard disposal container

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0180C	COVID-19 IgG/IgM Rapid Test CE	30/kit	S, P &WB

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Dengue Ag Rapid Test CE

Features:

In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen
Simple assay procedure yields results within 20-25 minutes

Clinical performance:

Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
Sensitivity: 100%
Specificity: 98.8% comparing to a commercial ELISA
Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
Plastic droppers
Sample diluent (REF SB-R0063, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0063C	Dengue Ag Rapid Test CE	30/kit	S, P &WB

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Dengue IgG/IgM Combo Rapid Test CE

Features:

Utilizes recombinant chimeric dengue virus licensed from the US CDC
Detects all four dengue serotypes
IgM detection indicates recent infection
IgG detection indicates recent or previous infections
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
5 µL capillary tubes
Sample diluent (REF SB-R0061, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0061C	Dengue IgG/IgM Combo Rapid Test CE	30/kit	S, P &WB

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Duo Dengue Ag-IgG/IgM Rapid Test CE

Features:

Utilizes recombinant chimeric dengue virus licensed from the US CDC
Detects all four dengue serotypes
Duo test format minimizes processing time
IgM detection indicates recent infection
IgG detection indicates recent or previous infections
Ag detection indicates a current infection
Individually sealed foil pouches containing:
- One cassette device
- One desiccant
5 µL Capillary tubes (for Dengue IgG/IgM test)
Plastic droppers (for Dengue Ag test)
Sample diluent (REF SB-R0062, 5 mL/bottle)
One package insert (instruction for use)

CATALOG #	PRODUCT	QUANTITY	SPECIMEN
R0062C	Duo Dengue Ag-IgG/IgM Rapid Test CE	30/kit	S, P &WB

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Duo HSV-1/2 IgG/IgM Rapid Test CE

Features:

Clinical accuracy:
90.6% sensitivity and 91.4% specificity for anti-HSV-1 IgG detection
93.8% sensitivity and 96.0% specificity for anti-HSV-2 IgG detection
85.0% overall agreement for anti-HSV-1 IgM detection comparing to commercial ELISA
100% overall agreement for anti-HSV-2 IgM detection comparing to BBI Panel (PTH202)
Positive rate on random clinical specimens:8% for IgG anti-HSV-1 and 4.9% for IgM anti-HSV-1 (n=10,000); 4.6% for anti-HSV-2 IgG and 1.7% for anti-HSV-2 IgM
Cross reactivity: no cross reactivity with the following disease states or special conditions, respectively: palladium, H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, hCG, TB, HAV, HBV, HCV, HEV, HIV, ANA, HAMA, RF (up to 1,000 IU/mL)
Interference: No interference was seen with Albumin 60 g/L , Hemoglobin 2 g/L, Bilirubin 20 mg/dL, Heparin 3,000 U/L, Creatinine 442 µmol/L, Salicylic acid 4.24 mmol/L, EDTA 3.4 µmol/L, Sodium citrate 8%, Glucose 55 mmol/L
Shelf life: 24 months
ndividually sealed foil pouches containing:
- One cassette device
- One desiccant
Capillary tubes (10 µL)
Sample diluent (REF SB-R0203, 5 mL/bottle)
Package insert (instruction for use)

CATALOG #	PRODUCT	QUANTOTY	SPECIMEN
R0218C	Duo HSV-1-2IgG/IgM Rapid Test CE	20/kit	S,P& WB

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